Heat IllnesslifebeamNCT01789931
Examination of a New Non Invasive Sensor "Lifebeam" During HTT in Protective Clothing
A study testing "Lifebeam" in people with Heat Illness, run by Sheba Medical Center at 1 site in Israel.
Trial summary
CB (Chemical Biological)protective clothing provides a thermal resistance between the human body and its environment. CB protective clothing will be essential for combat soldiers in case of non conventional attacks. "Lifebeam" developed a new non invasive sensor for body core temperature detection. Read more about this study
- Who is it for?
- Ages 21 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Heat Illness
- What is being tested?
- "Lifebeam"
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 21-30
- healthy
- after medical checkup
- after signing concent form
Who cannot join
- heart disease
- respiratory disease
- baseline bp above 140/90 mmHg
- sleep disorders
- diabetes
- anhydrosis
- skin disease
- acute illness in last 3 days prior to the examination
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sheba medical center
Tel-Hashomer, Ramat- Gan
Barliz Adato, MD, Barliz.Adato@sheba.health.gov.il
About this study
Official title: Examination of a New Non Invasive Sensor "Lifebeam" During HTT (Heat Tolerance Test) in Protective Clothing
CB (Chemical Biological)protective clothing provides a thermal resistance between the human body and its environment. CB protective clothing will be essential for combat soldiers in case of non conventional attacks. "Lifebeam" developed a new non invasive sensor for body core temperature detection. The research purpose is to evaluate the "Lifebeam" sensor during heat tolerance test while wearing CB protective clothing.
- Conditions
- Heat Illness
- Being tested
- "Lifebeam"
- Medical subject headings
- Heat Stress Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Lifebeam"Device
The "lifebeam" sensor will be attached to the participant's skin during the HTT.
| Study group | Role | What they receive |
|---|---|---|
| Research arm | Experimental | The participants will undergo an examination day in which they will complete VO2max test to evaluate their aerobic fitness. Afterwards they'll undergo 3 heat tolerance test (HTT) days: without CB protective clothing, with CB protective clothing, and with work clothes. During the tests, a "Lifebeam" sensor will be attached to their skin. Receives: Device: "Lifebeam" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heat tolerance test
The test is performed in a climatic chamber at a temperature of 40oC and 40% relative humidity. During the test, the subject walks on a treadmill at a speed of 5 km/hr at a 2% grade for 2h. Body core temperature and heart rate are continuously monitored, and sweat rate is computed from body weight prior to and after the test, corrected for fluid intake. Heat intolerance is determined when body core temperature elevates above 38.5oC, when heart rate elevates above 150 bpm, or when either does not tend to reach a plateau.
Measured: 1 year
VO2 test
Volunteer's oxygen consumption (VO2) will be monitored continuously with a metabolic chart (ZAN), while running for 10 min on a treadmill under comfortable environmental conditions.
Measured: 1 year
Secondary outcomes (4)
Skin temperature
The volunteers will undergo heat tolerance test. Their skin temperature will be measured by skin thermistors and will be monitored continuously and viewed by the attending medical staff. Automatically all data will be recorded by the monitoring Biopac system.
Measured: 1 year
Rectal temperature
The volunteers will undergo heat tolerance test. Their rectal temperature will be measured by rectal thermistor and will be monitored continuously and viewed by the attending medical staff. Automatically all data will be recorded by the monitoring Biopac system.
Measured: 1 year
Heart rate
During the HTT and the VO2 test heart rates will be monitored continuously and will be stored by a heart rate wristwatch, (POLAR, Finland).
Measured: 1 year
blood circulation parameters
Evaluation by the optic sensor "Lifebeam" of the blood circulation parameters (heart rate, blood flow velocity, perfusion, and ventilation rate) in the peripheral arterioles
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study startDec 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat IllnessStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Barliz Adato, Sheba Medical Center
- Investigators
- Barliz Adato, MD, Principal investigator, Heller institute, Sheba medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789931
- Sponsor's protocol ID
- SHEBA-12-9435-BA-CTIL
- Acronym
- lifebeam
- Status last verified
- May 2014
- First submitted
- 6 Dec 2012
- Last updated
- 8 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of a New Non Invasive Sensor "Lifebeam" During HTT (Heat Tolerance Test) in Protective Clothing
- ClinicalTrials.gov ID
- NCT01789931
- Acronym / sponsor ID
- lifebeam / SHEBA-12-9435-BA-CTIL
- Conditions
- Heat Illness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 12 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CB (Chemical Biological)protective clothing provides a thermal resistance between the human body and its environment. CB protective clothing will be essential for combat soldiers in case of non conventional attacks. "Lifebeam" developed a new non invasive sensor for body core temperature detection. The research purpose is to evaluate the "Lifebeam" sensor during heat tolerance test while wearing CB protective clothing.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research arm | Experimental | Device: "Lifebeam"The participants will undergo an examination day in which they will complete VO2max test to evaluate their aerobic fitness. Afterwards they'll undergo 3 heat tolerance test (HTT) days: without CB protective clothing, with CB protective clothing, and with work clothes. During the tests, a "Lifebeam" sensor will be attached to their skin. |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 21-30
- healthy
- after medical checkup
- after signing concent form
Key exclusion criteria (8 listed)
- heart disease
- respiratory disease
- baseline bp above 140/90 mmHg
- sleep disorders
- diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Lifebeam"The "lifebeam" sensor will be attached to the participant's skin during the HTT. | Device | Research arm |
Primary outcome
Heat tolerance test
Time frame: 1 year
The test is performed in a climatic chamber at a temperature of 40oC and 40% relative humidity. During the test, the subject walks on a treadmill at a speed of 5 km/hr at a 2% grade for 2h. Body core temperature and heart rate are continuously monitored, and sweat rate is computed from body weight prior to and after the test, corrected for fluid intake. Heat intolerance is determined when body core temperature elevates above 38.5oC, when heart rate elevates above 150 bpm, or when either does not tend to reach a plateau.
VO2 test
Time frame: 1 year
Volunteer's oxygen consumption (VO2) will be monitored continuously with a metabolic chart (ZAN), while running for 10 min on a treadmill under comfortable environmental conditions.
4 secondary outcomes
Skin temperature
Time frame: 1 year
Rectal temperature
Time frame: 1 year
Heart rate
Time frame: 1 year
blood circulation parameters
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barliz Adato, MD principal investigator
Heller institute, Sheba medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Lifebeam" in people with Heat Illness, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barliz Adato, MD (+972542662201, Barliz.Adato@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heat tolerance test (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2014.